Post-Market Observation Study of Intra-renal Drug Delivery (PROVIDE)

Sponsor

Angiodynamics, Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT01064895

Collaborator

(none)

Locations

21.9

Duration (Months)

Study Details

Study Description

Brief Summary

This is a prospective, observational, multi-center study with consecutive enrollment. Up to 500 patients will be enrolled. All (consecutive) adult patients in whom one or more components of the Benephit Infusion System are planned to be used at participating sites are eligible for enrollment. The objective of this post-marketing surveillance study is to collect clinical usage patterns of the Benephit Infusion Systems. As a result, AngioDynamics will be able to (1) Better understand and quantify usage patterns including patient characteristics, adjunctive procedures, and infusion agents, (2) Collect user-interface information and overall customer satisfaction, and (3) Monitor post-marketing device performance and safety for ISO quality adherence.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury Acute Renal Failure Renal Failure Chronic Contrast Induced Chronic Kidney Disease	Device: Benephit catheter for Targeted Renal Therapy

Detailed Description

Acute kidney injury, or AKI, is a rapid decline in renal function characterized by a decrease in urine output and/or an increase in serum creatinine (Cr), and is associated with worsened clinical outcomes and increased healthcare costs. AKI may be caused by numerous factors including interruptions or perturbations of renal blood flow or toxins, and often these factors are extra-renal in origin. AKI diagnoses in hospitalized patients are over one million per year and are projected to continue to grow, due largely to the aging population and increasing numbers of medical and invasive procedures performed on the elderly and the ever-increasing prevalence of diabetes mellitus and its medical complications, as well as increasing awareness within the medical community.

Treatment options for established acute kidney injury are limited and consist mainly of fluid and electrolyte balance (diuretics and/or IV fluids) supportive care up until the point that dialysis or other renal replacement therapy (RRT) is required. Despite the advent of newer drugs, more sophisticated RRT equipment, and increased awareness of the problem, little has changed relative to patient outcomes, which remain poor. Similarly, limited options exist in patients with known risk factors for AKI to prevent its development due to iatrogenic causes (e.g., major surgery, exposure to contrast media).

Targeted Renal Therapy allows for direct delivery of therapeutically relevant doses of various pharmacological agents directly to the renal bed, potentially reducing dose limiting side effects of traditional IV therapy. With Targeted Renal Therapy, or TRT, the kidney can metabolize, conjugate, and/or clear a substantial portion of many agents immediately (known as the "renal first-pass" effect), reducing the amount that is returned to the systemic circulation via the renal veins, thus potentially reducing untoward side effects. While the existence of a renal first-pass effect has been hypothesized in the medical literature for some time, it has not been possible to take clinical advantage of this important physiological function prior to the advent of AngioDynamics' TRT. Thus, TRT has the potential to offer an additional preventative or treatment opportunity in those patients at risk for AKI, or with established AKI, respectively.

Study Design

Study Type:

Observational

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Post-Market Observation Study of Intra-renal Drug Delivery (PROVIDE)

Study Start Date :

Feb 1, 2010

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Cohort Patients receiving the Benephit device and targeted renal therapy.	Device: Benephit catheter for Targeted Renal Therapy Local physician-specified agent delivery to the kidneys bilaterally via the renal arteries using the Benephit infusion system. Other Names: Benephit CV,PV,XT Infusion Systems(K033569,K050205,K082163)

Arm

Intervention/Treatment

Active Cohort

Patients receiving the Benephit device and targeted renal therapy.

Device: Benephit catheter for Targeted Renal Therapy

Local physician-specified agent delivery to the kidneys bilaterally via the renal arteries using the Benephit infusion system.

Other Names:

Benephit CV,PV,XT Infusion Systems(K033569,K050205,K082163)

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Physician-determined need for Benephit device/Targeted Renal Therapy
Age >=18 years
Ability to provide written informed consent

Exclusion Criteria:

Patients who are participating in another IRB approved research study that precludes simultaneous enrollment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baptist Cardiac & Vascular Institute	Miami	Florida	United States	33176
2	HealthwoRx South Florida Research Solutions	Miramar	Florida	United States	33025
3	Bingham Memorial Hospital	Blackfoot	Idaho	United States	83221
4	Cardiology Associates of NW Indiana	Munster	Indiana	United States	46321
5	Midwest Cardiovascular Research Foundation	Davenport	Iowa	United States	52803
6	King's Daughters Medical Center	Ashland	Kentucky	United States	41101
7	Graves Gilbert Clinic	Bowling Green	Kentucky	United States	42101
8	Sahetya Medical Institute	Bowling Green	Kentucky	United States	42101
9	Western Kentucky Heart and Lung	Bowling Green	Kentucky	United States	42101
10	University of Maryland Medical Center	Baltimore	Maryland	United States	42101
11	St. John Hospital & Medical Center	Detroit	Michigan	United States	48236
12	St. Joseph Health Center	St. Charles	Missouri	United States	63301
13	Chambersburg Hospital	Chambersburg	Pennsylvania	United States	17201
14	Utah Cardiology PC	Layton	Utah	United States	84041
15	Virginia Commonwealth University Medical Center	Richmond	Virginia	United States	23298